Skip to content
← Full study record

NCT03504397 · ADVERSE EVENTS

Adverse events

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. · Source last updated 2026-05-04

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
All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
Other-event reporting threshold
5%

Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Zolbetuximab

Participants received an IV infusion (as a minimum of 2-hourinfusion) ofzolbetuximab at a loading dose of 800mg/m\^2 on C1D1followed by subsequent doses of 600 mg/m\^2every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria .Each cycle wasapproximately 42 days.

133 / 279276 / 279197 / 283
5-fluorouracil

Participants received up to 12 treatments of5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m\^2 over5 to 15 minutes followed by 2400mg/m\^2 over46-48 hours continuous IV infusion every 2weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.

262 / 557550 / 557414 / 565
Folinic Acid / Leucovorin

Participants received up to 12 treatments of folinic acid administered 400mg/m\^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and29 of each cycle. Participants could continue to receive folinic acid on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.

262 / 557550 / 557414 / 565
Oxaliplatin

Participants received up to 12 treatments of oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours) on Days 1,15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42days.

262 / 557550 / 557414 / 565
Placebo

Participants received anIV infusion (as a minimum of 2-hourinfusion) of placebo matched to zolbetuximab on C1D1followed by subsequent doses every 3 weeks starting from C1D22until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.

129 / 278274 / 278217 / 282

Group identifiers: EG000: Zolbetuximab · EG001: 5-fluorouracil · EG002: Folinic Acid / Leucovorin · EG003: Oxaliplatin · EG004: Placebo

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 v25
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      279
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      557
      num Events
      10
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      557
      num Events
      10
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      557
      num Events
      10
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      278
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      278
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      279
      num Events
      8
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      557
      num Events
      9
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      557
      num Events
      9
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      557
      num Events
      9
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Microangiopathic haemolytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      279
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      557
      num Events
      9
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      557
      num Events
      9
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      557
      num Events
      9
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      278
      num Events
      3
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      278
      num Events
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      557
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      557
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      557
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      557
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      557
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      557
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      278
      num Events
      0
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      557
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      557
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      557
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      278
      num Events
      2
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Cardio-respiratory arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Myocardial infarction

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      279
      num Events
      309
    2. group Id
      EG001
      num Affected
      211
      num At Risk
      557
      num Events
      616
    3. group Id
      EG002
      num Affected
      211
      num At Risk
      557
      num Events
      616
    4. group Id
      EG003
      num Affected
      211
      num At Risk
      557
      num Events
      616
    5. group Id
      EG004
      num Affected
      106
      num At Risk
      278
      num Events
      307
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      279
      num Events
      34
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      557
      num Events
      57
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      557
      num Events
      57
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      557
      num Events
      57
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      278
      num Events
      23
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      279
      num Events
      340
    2. group Id
      EG001
      num Affected
      195
      num At Risk
      557
      num Events
      674
    3. group Id
      EG002
      num Affected
      195
      num At Risk
      557
      num Events
      674
    4. group Id
      EG003
      num Affected
      195
      num At Risk
      557
      num Events
      674
    5. group Id
      EG004
      num Affected
      94
      num At Risk
      278
      num Events
      334
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      279
      num Events
      67
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      557
      num Events
      180
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      557
      num Events
      180
    4. group Id
      EG003
      num Affected
      74
      num At Risk
      557
      num Events
      180
    5. group Id
      EG004
      num Affected
      45
      num At Risk
      278
      num Events
      113
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      279
      num Events
      23
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      557
      num Events
      50
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      557
      num Events
      50
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      557
      num Events
      50
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      278
      num Events
      27
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      279
      num Events
      137
    2. group Id
      EG001
      num Affected
      154
      num At Risk
      557
      num Events
      274
    3. group Id
      EG002
      num Affected
      154
      num At Risk
      557
      num Events
      274
    4. group Id
      EG003
      num Affected
      154
      num At Risk
      557
      num Events
      274
    5. group Id
      EG004
      num Affected
      86
      num At Risk
      278
      num Events
      137
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      279
      num Events
      76
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      557
      num Events
      124
    3. group Id
      EG002
      num Affected
      80
      num At Risk
      557
      num Events
      124
    4. group Id
      EG003
      num Affected
      80
      num At Risk
      557
      num Events
      124
    5. group Id
      EG004
      num Affected
      33
      num At Risk
      278
      num Events
      48
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      279
      num Events
      154
    2. group Id
      EG001
      num Affected
      212
      num At Risk
      557
      num Events
      334
    3. group Id
      EG002
      num Affected
      212
      num At Risk
      557
      num Events
      334
    4. group Id
      EG003
      num Affected
      212
      num At Risk
      557
      num Events
      334
    5. group Id
      EG004
      num Affected
      111
      num At Risk
      278
      num Events
      180
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      279
      num Events
      202
    2. group Id
      EG001
      num Affected
      237
      num At Risk
      557
      num Events
      477
    3. group Id
      EG002
      num Affected
      237
      num At Risk
      557
      num Events
      477
    4. group Id
      EG003
      num Affected
      237
      num At Risk
      557
      num Events
      477
    5. group Id
      EG004
      num Affected
      125
      num At Risk
      278
      num Events
      275
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      279
      num Events
      35
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      557
      num Events
      60
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      557
      num Events
      60
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      557
      num Events
      60
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      278
      num Events
      25
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      279
      num Events
      28
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      557
      num Events
      62
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      557
      num Events
      62
    4. group Id
      EG003
      num Affected
      43
      num At Risk
      557
      num Events
      62
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      278
      num Events
      34
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      279
      num Events
      16
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      557
      num Events
      32
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      557
      num Events
      32
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      557
      num Events
      32
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      278
      num Events
      16
    term
    Gastrooesophageal reflux disease
Complete source fields
description
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
event Groups
  1. deaths Num Affected
    197
    deaths Num At Risk
    283
    description
    Participants received an IV infusion (as a minimum of 2-hourinfusion) ofzolbetuximab at a loading dose of 800mg/m\^2 on C1D1followed by subsequent doses of 600 mg/m\^2every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria .Each cycle wasapproximately 42 days.
    id
    EG000
    other Num Affected
    276
    other Num At Risk
    279
    serious Num Affected
    133
    serious Num At Risk
    279
    title
    Zolbetuximab
  2. deaths Num Affected
    414
    deaths Num At Risk
    565
    description
    Participants received up to 12 treatments of5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m\^2 over5 to 15 minutes followed by 2400mg/m\^2 over46-48 hours continuous IV infusion every 2weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
    id
    EG001
    other Num Affected
    550
    other Num At Risk
    557
    serious Num Affected
    262
    serious Num At Risk
    557
    title
    5-fluorouracil
  3. deaths Num Affected
    414
    deaths Num At Risk
    565
    description
    Participants received up to 12 treatments of folinic acid administered 400mg/m\^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and29 of each cycle. Participants could continue to receive folinic acid on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
    id
    EG002
    other Num Affected
    550
    other Num At Risk
    557
    serious Num Affected
    262
    serious Num At Risk
    557
    title
    Folinic Acid / Leucovorin
  4. deaths Num Affected
    414
    deaths Num At Risk
    565
    description
    Participants received up to 12 treatments of oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours) on Days 1,15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42days.
    id
    EG003
    other Num Affected
    550
    other Num At Risk
    557
    serious Num Affected
    262
    serious Num At Risk
    557
    title
    Oxaliplatin
  5. deaths Num Affected
    217
    deaths Num At Risk
    282
    description
    Participants received anIV infusion (as a minimum of 2-hourinfusion) of placebo matched to zolbetuximab on C1D1followed by subsequent doses every 3 weeks starting from C1D22until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.
    id
    EG004
    other Num Affected
    274
    other Num At Risk
    278
    serious Num Affected
    129
    serious Num At Risk
    278
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      105
      num At Risk
      279
      num Events
      309
    2. group Id
      EG001
      num Affected
      211
      num At Risk
      557
      num Events
      616
    3. group Id
      EG002
      num Affected
      211
      num At Risk
      557
      num Events
      616
    4. group Id
      EG003
      num Affected
      211
      num At Risk
      557
      num Events
      616
    5. group Id
      EG004
      num Affected
      106
      num At Risk
      278
      num Events
      307
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      279
      num Events
      34
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      557
      num Events
      57
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      557
      num Events
      57
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      557
      num Events
      57
    5. group Id
      EG004
      num Affected
      13
      num At Risk
      278
      num Events
      23
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      279
      num Events
      340
    2. group Id
      EG001
      num Affected
      195
      num At Risk
      557
      num Events
      674
    3. group Id
      EG002
      num Affected
      195
      num At Risk
      557
      num Events
      674
    4. group Id
      EG003
      num Affected
      195
      num At Risk
      557
      num Events
      674
    5. group Id
      EG004
      num Affected
      94
      num At Risk
      278
      num Events
      334
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      279
      num Events
      67
    2. group Id
      EG001
      num Affected
      74
      num At Risk
      557
      num Events
      180
    3. group Id
      EG002
      num Affected
      74
      num At Risk
      557
      num Events
      180
    4. group Id
      EG003
      num Affected
      74
      num At Risk
      557
      num Events
      180
    5. group Id
      EG004
      num Affected
      45
      num At Risk
      278
      num Events
      113
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      279
      num Events
      23
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      557
      num Events
      50
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      557
      num Events
      50
    4. group Id
      EG003
      num Affected
      39
      num At Risk
      557
      num Events
      50
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      278
      num Events
      27
    term
    Abdominal distension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      279
      num Events
      137
    2. group Id
      EG001
      num Affected
      154
      num At Risk
      557
      num Events
      274
    3. group Id
      EG002
      num Affected
      154
      num At Risk
      557
      num Events
      274
    4. group Id
      EG003
      num Affected
      154
      num At Risk
      557
      num Events
      274
    5. group Id
      EG004
      num Affected
      86
      num At Risk
      278
      num Events
      137
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      279
      num Events
      76
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      557
      num Events
      124
    3. group Id
      EG002
      num Affected
      80
      num At Risk
      557
      num Events
      124
    4. group Id
      EG003
      num Affected
      80
      num At Risk
      557
      num Events
      124
    5. group Id
      EG004
      num Affected
      33
      num At Risk
      278
      num Events
      48
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      279
      num Events
      154
    2. group Id
      EG001
      num Affected
      212
      num At Risk
      557
      num Events
      334
    3. group Id
      EG002
      num Affected
      212
      num At Risk
      557
      num Events
      334
    4. group Id
      EG003
      num Affected
      212
      num At Risk
      557
      num Events
      334
    5. group Id
      EG004
      num Affected
      111
      num At Risk
      278
      num Events
      180
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      279
      num Events
      202
    2. group Id
      EG001
      num Affected
      237
      num At Risk
      557
      num Events
      477
    3. group Id
      EG002
      num Affected
      237
      num At Risk
      557
      num Events
      477
    4. group Id
      EG003
      num Affected
      237
      num At Risk
      557
      num Events
      477
    5. group Id
      EG004
      num Affected
      125
      num At Risk
      278
      num Events
      275
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      279
      num Events
      35
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      557
      num Events
      60
    3. group Id
      EG002
      num Affected
      48
      num At Risk
      557
      num Events
      60
    4. group Id
      EG003
      num Affected
      48
      num At Risk
      557
      num Events
      60
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      278
      num Events
      25
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      279
      num Events
      28
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      557
      num Events
      62
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      557
      num Events
      62
    4. group Id
      EG003
      num Affected
      43
      num At Risk
      557
      num Events
      62
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      278
      num Events
      34
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      279
      num Events
      16
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      557
      num Events
      32
    3. group Id
      EG002
      num Affected
      30
      num At Risk
      557
      num Events
      32
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      557
      num Events
      32
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      278
      num Events
      16
    term
    Gastrooesophageal reflux disease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      279
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      557
      num Events
      10
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      557
      num Events
      10
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      557
      num Events
      10
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      278
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      278
      num Events
      0
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      279
      num Events
      8
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      557
      num Events
      9
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      557
      num Events
      9
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      557
      num Events
      9
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Microangiopathic haemolytic anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      279
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      557
      num Events
      9
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      557
      num Events
      9
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      557
      num Events
      9
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      278
      num Events
      3
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      278
      num Events
      0
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      557
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      557
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      557
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      279
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      557
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      557
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      557
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      278
      num Events
      0
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Cardiac arrest
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      557
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      557
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      557
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      278
      num Events
      2
    term
    Cardiac failure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Cardio-respiratory arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      557
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      557
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      557
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      278
      num Events
      1
    term
    Myocardial infarction
time Frame
All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice