Skip to content
← Full study record

NCT02718417 · ADVERSE EVENTS

Adverse events

Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) · Source last updated 2020-07-14

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
Baseline up to maximum duration of 36 months
Other-event reporting threshold
5%

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Chemotherapy Followed by Avelumab

In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg\*min/mL) x (glomerular filtration rate\[GFR\] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.

92 / 328320 / 32834 / 328
Chemotherapy + Avelumab Followed by Avelumab

In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose \[milligrams\](mg) = Target AUC (mg\*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.

118 / 329325 / 32931 / 329
Chemotherapy Followed by Observation

In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose \[milligrams\](mg) = Target AUC \[milligrams\*minute per milliliter\] (mg\*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.

64 / 334317 / 33420 / 334

Group identifiers: EG000: Chemotherapy Followed by Avelumab · EG001: Chemotherapy + Avelumab Followed by Avelumab · EG002: Chemotherapy Followed by Observation

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal abscess
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      334
    term
    Abdominal distension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal hernia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      334
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal pain lower
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal pain upper
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal wall abscess
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Acute kidney injury
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MMedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Adrenal insufficiency
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      334
    term
    Anaemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Anal haemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Anaphylactic shock

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      334
    term
    Abdominal distension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      334
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      334
    term
    Abdominal pain upper
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      334
    term
    Alanine aminotransferase increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      167
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      169
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      177
      num At Risk
      334
    term
    Alopecia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      151
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      140
      num At Risk
      334
    term
    Anaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      334
    term
    Anxiety
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      334
    term
    Arthralgia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      334
    term
    Aspartate aminotransferase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      334
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      334
    term
    Back pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      95
      num At Risk
      334
    term
    Constipation
Complete source fields
description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.
event Groups
  1. deaths Num Affected
    34
    deaths Num At Risk
    328
    description
    In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg\*min/mL) x (glomerular filtration rate\[GFR\] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
    id
    EG000
    other Num Affected
    320
    other Num At Risk
    328
    serious Num Affected
    92
    serious Num At Risk
    328
    title
    Chemotherapy Followed by Avelumab
  2. deaths Num Affected
    31
    deaths Num At Risk
    329
    description
    In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose \[milligrams\](mg) = Target AUC (mg\*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
    id
    EG001
    other Num Affected
    325
    other Num At Risk
    329
    serious Num Affected
    118
    serious Num At Risk
    329
    title
    Chemotherapy + Avelumab Followed by Avelumab
  3. deaths Num Affected
    20
    deaths Num At Risk
    334
    description
    In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose \[milligrams\](mg) = Target AUC \[milligrams\*minute per milliliter\] (mg\*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
    id
    EG002
    other Num Affected
    317
    other Num At Risk
    334
    serious Num Affected
    64
    serious Num At Risk
    334
    title
    Chemotherapy Followed by Observation
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      334
    term
    Abdominal distension
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      334
    term
    Abdominal pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      334
    term
    Abdominal pain upper
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      334
    term
    Alanine aminotransferase increased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      167
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      169
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      177
      num At Risk
      334
    term
    Alopecia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      151
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      140
      num At Risk
      334
    term
    Anaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      334
    term
    Anxiety
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      57
      num At Risk
      334
    term
    Arthralgia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      334
    term
    Aspartate aminotransferase increased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      334
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      334
    term
    Back pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      113
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      95
      num At Risk
      334
    term
    Constipation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal abscess
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      334
    term
    Abdominal distension
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal hernia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      334
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal pain lower
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal pain upper
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Abdominal wall abscess
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Acute kidney injury
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MMedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Adrenal insufficiency
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      334
    term
    Anaemia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Anal haemorrhage
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA v22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      328
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      334
    term
    Anaphylactic shock
time Frame
Baseline up to maximum duration of 36 months

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

Preserved source evidence · Not medical advice