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NCT01609556 · ADVERSE EVENTS

Adverse events

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Mirvetuximab Soravtansine in Adults With Ovarian Cancer and Other Folate Receptor 1 (FOLR1)-Positive Solid Tumors · Source last updated 2021-02-17

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
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
Other-event reporting threshold
0%

Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data was only collected and reported by combined groups for the dose-escalation phase and not by individual doses.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)

Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

2 / 22 / 22 / 2
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)

Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

0 / 10 / 10 / 1
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

1 / 11 / 10 / 1
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

0 / 11 / 10 / 1
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)

Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

0 / 99 / 90 / 9
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

5 / 1818 / 181 / 18
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

1 / 77 / 70 / 7
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)

Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

2 / 55 / 50 / 5
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)

Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

2 / 55 / 50 / 5
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)

Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

3 / 44 / 40 / 4
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)

Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

4 / 99 / 91 / 9
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)

Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

4 / 77 / 70 / 7
Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)

Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

18 / 4645 / 464 / 46
Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)

Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

11 / 2424 / 244 / 24
Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)

Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

9 / 2727 / 271 / 27
Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)

Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.

17 / 4040 / 404 / 40

Group identifiers: EG000: Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) · EG001: Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) · EG002: Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) · EG003: Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) · EG004: Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) · EG005: Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) · EG006: Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) · EG007: Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) · EG008: Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) · EG009: Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) · EG010: Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) · EG011: Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) · EG012: Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) · EG013: Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) · EG014: Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) · EG015: Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Small intestinal obstruction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Gastritis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Corneal opacity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Punctate keratitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hip fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Humerus fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hypokalaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hypomagnesaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hypophosphataemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hypoxia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Pulmonary oedema

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      5
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      6
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      7
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      7
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Gingival bleeding
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Mouth ulceration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Oral dysaesthesia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Retching
Complete source fields
description
Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data was only collected and reported by combined groups for the dose-escalation phase and not by individual doses.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    2
    description
    Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
  4. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG003
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
  5. deaths Num Affected
    0
    deaths Num At Risk
    9
    description
    Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG004
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    0
    serious Num At Risk
    9
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
  6. deaths Num Affected
    1
    deaths Num At Risk
    18
    description
    Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG005
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    5
    serious Num At Risk
    18
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
  7. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG006
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
  8. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG007
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
  9. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG008
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
  10. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG009
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    3
    serious Num At Risk
    4
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
  11. deaths Num Affected
    1
    deaths Num At Risk
    9
    description
    Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG010
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
  12. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
    id
    EG011
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      5
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      6
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      7
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      7
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      7
    term
    Abdominal pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Dry mouth
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      7
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Gingival bleeding
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Mouth ulceration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Oral dysaesthesia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Retching
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Small intestinal obstruction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Gastritis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Corneal opacity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Punctate keratitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hip fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Humerus fracture
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hypokalaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hypomagnesaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hypophosphataemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Hypoxia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 17.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      18
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      5
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      9
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      7
    term
    Pulmonary oedema
time Frame
From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)

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Preserved source evidence · Not medical advice