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NCT04106492 · ADVERSE EVENTS

Adverse events

Phase 1/2a Study of SQ3370 in Patients With Advanced Solid Tumors · Source last updated 2025-11-14

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
1 year
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

1 / 11 / 11 / 1
Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

0 / 11 / 10 / 1
Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

1 / 11 / 10 / 1
Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

2 / 33 / 30 / 3
Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

2 / 33 / 30 / 3
Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

0 / 44 / 40 / 4
Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

2 / 44 / 40 / 4
Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

2 / 77 / 70 / 7
Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

0 / 66 / 60 / 6
Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)

20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

1 / 55 / 50 / 5
Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)

20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

1 / 33 / 30 / 3
Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors

0 / 11 / 10 / 1
Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33)

20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with soft tissue sarcomas of the extremity

0 / 22 / 20 / 2
P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day)

10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 500 mg/m\^2 of SQP33 infused on Day 1 and 2 with 250 mg/m\^2 of SQP33 infused on each Day 3 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve

2 / 66 / 61 / 6
P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)

10 mL of SQL70 injected intratumorally on Day with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced, unresectable or metastatic soft tissue sarcomas who are anthracycline naïve

1 / 66 / 60 / 6

Group identifiers: EG000: Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33) · EG001: Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33) · EG002: Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33) · EG003: Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33) · EG004: Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33) · EG005: Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33) · EG006: Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33) · EG007: Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33) · EG008: Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33) · EG009: Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33) · EG010: Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33) · EG011: Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33) · EG012: Phase 2a Expansion Group 1 (Extremity STS) (20 mL SQL70 and 250 mg/m^2/Day of SQP33) · EG013: P2a Grp 2 (10 mL SQL70 and 500 mg/m^2/ of SQP33 for 2 Days and and 250 mg/m^2/ of SQP33 for 1 Day) · EG014: P2a Grp 2 (10 mL SQL70 and 250 mg/m^2/Day of SQP33 for Five Days)

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 (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Haemorrhagic transformation stroke
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Device related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Dyspnoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Flank pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    General physical health deterioration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Nausea

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 (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    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
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Stomatitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Abdominal Pain Upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Abdominal Discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Abdominal Distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Abdominal Pain Lower
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Colonic Fistula
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Dysphagia
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 8 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Escalation Cohort 1 (10 mL SQL70 and 8 mg/m^2 of SQP33)
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 16 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Dose Escalation Cohort 2 (10 mL SQL70 and 16 mg/m^2 of SQP33)
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 32 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Dose Escalation Cohort 3 (10 mL SQL70 and 32 mg/m^2 of SQP33)
  4. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 58 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Dose Escalation Cohort 4 (10 mL SQL70 and 58 mg/m^2 of SQP33)
  5. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Dose Escalation Cohort 5 (10 mL SQL70 and 85 mg/m^2 of SQP33)
  6. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG005
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Dose Escalation Cohort 6 (10 mL SQL70 and 125 mg/m^2 of SQP33)
  7. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG006
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Dose Escalation Cohort 7 (10 mL SQL70 and 185 mg/m^2 of SQP33)
  8. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 250 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG007
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    Dose Escalation Cohort 8 (10 mL SQL70 and 250 mg/m^2 of SQP33)
  9. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 315 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG008
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Dose Escalation Cohort 9 (10 mL SQL70 and 315 mg/m^2 of SQP33)
  10. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 85 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG009
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Dose Escalation Cohort (20 mL SQL70 and 85 mg/m^2 of SQP33)
  11. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    20 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 125 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG010
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Dose Escalation Cohort (20 mL SQL70 and 125 mg/m^2 of SQP33)
  12. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    10 mL of SQL70 injected intratumorally on Day 1 of each 21-day cycle into a single lesion with 185 mg/m\^2 of SQP33 infused each day on Day 1 through Day 5 in subjects with locally advanced or metastatic solid tumors
    id
    EG011
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Cohort A (10 mL SQL70 and 185 mg/m^2 of SQP33)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    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
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Stomatitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    2. group Id
      EG001
      num Affected
      1
      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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Abdominal Pain Upper
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Abdominal Discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Abdominal Distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Abdominal Pain Lower
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Colonic Fistula
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Dysphagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Haemorrhagic transformation stroke
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Dehydration
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Device related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Dyspnoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Febrile neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Flank pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    General physical health deterioration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Hypotension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1
    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
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      4
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      4
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      3
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Nausea
time Frame
1 year

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Preserved source evidence · Not medical advice