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NCT02988817 · ADVERSE EVENTS

Adverse events

Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors · Source last updated 2023-08-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)
Other-event reporting threshold
0%

The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.

0 / 11 / 10 / 1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.

0 / 11 / 11 / 1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.

0 / 33 / 33 / 3
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.

2 / 33 / 31 / 3
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.

7 / 1010 / 106 / 10
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

6 / 1111 / 1110 / 11
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.

2 / 33 / 31 / 3
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.

1 / 33 / 32 / 3
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.

0 / 33 / 31 / 3
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

2 / 66 / 65 / 6
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W

Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.

3 / 33 / 31 / 3
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC with classical sensitizing classical EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

15 / 2222 / 228 / 22
Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic melanoma with BRAF V600 mutation received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

5 / 1616 / 169 / 16
Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic melanoma with BRAF V600 wild type received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

16 / 2524 / 2517 / 25
Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic sarcoma received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

10 / 2525 / 2518 / 25
Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with advanced and/or metastatic solid tumors (excluding NSCLC, melanoma, sarcoma, and ovarian cancer unless having a known AXL gene amplification) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

16 / 4444 / 4430 / 44
Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic platinum-resistant ovarian cancer received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

12 / 2525 / 2517 / 25
Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.

33 / 5656 / 5638 / 56
Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.8 mg/kg 1Q3W until the end of treatment.

7 / 2020 / 2014 / 22
Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Participants with advanced and/or metastatic NSCLC without activating EGFR mutations or ALK rearrangements received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.

14 / 2623 / 2616 / 26

Group identifiers: EG000: Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W · EG001: Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W · EG002: Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W · EG003: Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W · EG004: Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W · EG005: Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W · EG006: Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W · EG007: Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W · EG008: Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W · EG009: Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W · EG010: Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W · EG011: Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W · EG012: Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W · EG013: Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W · EG014: Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W · EG015: Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W · EG016: Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W · EG017: Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W · EG018: Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W · EG019: Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Atrial Fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cardiac Tamponade
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Supraventricular Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Adrenal Insufficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Inappropriate Antidiuretic Hormone Secretion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Abdominal Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Abdominal Pain Upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      10
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      7
      num At Risk
      22
      num Events
      7
    term
    Constipation

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      10
      num Events
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      6
      num Events
      10
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      22
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia Macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia of chronic disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Coagulopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Febrile Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Iron Deficiency Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Leukocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      10
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      22
      num Events
      9
    term
    Leukopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Lymphadenopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Lymphopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      10
      num Events
      29
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      11
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      22
      num Events
      6
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Normocytic Anaemia
Complete source fields
description
The TEAEs were evaluated per the safety set and all-cause mortality was evaluated per the full analysis set.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.3 mg/kg 1Q3W until the end of treatment.
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W
  2. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 1Q3W until the end of treatment.
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W
  3. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 1Q3W until the end of treatment.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W
  4. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.5 mg/kg 1Q3W until the end of treatment.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W
  5. deaths Num Affected
    6
    deaths Num At Risk
    10
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.0 mg/kg 1Q3W until the end of treatment.
    id
    EG004
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    7
    serious Num At Risk
    10
    title
    Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W
  6. deaths Num Affected
    10
    deaths Num At Risk
    11
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    EG005
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    6
    serious Num At Risk
    11
    title
    Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W
  7. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 2.4 mg/kg 1Q3W until the end of treatment.
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W
  8. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.6 mg/kg 3Q4W until the end of treatment.
    id
    EG007
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W
  9. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 0.8 mg/kg 3Q4W until the end of treatment.
    id
    EG008
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W
  10. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.0 mg/kg 3Q4W until the end of treatment.
    id
    EG009
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W
  11. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants with relapsed/refractory cancer (ovarian, cervical, endometrial, thyroid, NSCLC, or melanoma) received IV infusion of enapotamab vedotin 1.2 mg/kg 3Q4W until the end of treatment.
    id
    EG010
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W
  12. deaths Num Affected
    8
    deaths Num At Risk
    22
    description
    Participants with advanced and/or metastatic NSCLC with classical sensitizing classical EGFR mutations and/or EGFR mutations targeted by third-generation tyrosine kinase inhibitors) received IV infusion of enapotamab vedotin 2.2 mg/kg 1Q3W until the end of treatment.
    id
    EG011
    other Num Affected
    22
    other Num At Risk
    22
    serious Num Affected
    15
    serious Num At Risk
    22
    title
    Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      2
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      10
      num Events
      8
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      6
      num Events
      10
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      4
      num At Risk
      22
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia Macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia of chronic disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Coagulopathy
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Febrile Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Iron Deficiency Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Leukocytosis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      10
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      22
      num Events
      9
    term
    Leukopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Lymphadenopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      10
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Lymphopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
      num Events
      4
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      10
      num Events
      29
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      11
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      2
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      22
      num Events
      6
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Normocytic Anaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
      num Events
      1
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Atrial Fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Cardiac Tamponade
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Supraventricular Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Adrenal Insufficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Inappropriate Antidiuretic Hormone Secretion
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Abdominal Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Abdominal Pain Upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      10
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      3
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      6
      num Events
      0
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      22
      num Events
      0
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (v24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      10
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
      num Events
      2
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      3
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      6
      num Events
      1
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
      num Events
      0
    12. group Id
      EG011
      num Affected
      7
      num At Risk
      22
      num Events
      7
    term
    Constipation
time Frame
For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice