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NCT02580058 · ADVERSE EVENTS

Adverse events

A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200) · Source last updated 2023-07-10

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
AEs (serious and non-serious) should be reported from the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months). Based on the cutoff: 13 July 2022.
Other-event reporting threshold
5%

The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. The mortality analysis set included all randomized participants. The AE and SAE analysis set included participants who received at least 1 dose of study drug.

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

Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.

72 / 187173 / 187122 / 187
Avelumab + PLD

Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.

74 / 182176 / 182107 / 182
Pegylated Liposomal Doxorubicin (PLD)

PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.

51 / 177167 / 177116 / 177

Group identifiers: EG000: Avelumab · EG001: Avelumab + PLD · EG002: Pegylated Liposomal Doxorubicin (PLD)

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      182
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      182
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      187
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      182
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      182
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Basedow's disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      182
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Hypopituitarism
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      187
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Retinal detachment
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Administration site extravasation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      182
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Asthenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      187
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Chest discomfort

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      187
      num Events
      68
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      182
      num Events
      131
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      177
      num Events
      77
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      187
      num Events
      2
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      182
      num Events
      58
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      177
      num Events
      52
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      187
      num Events
      11
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      182
      num Events
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      177
      num Events
      2
    term
    Hypothyroidism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      187
      num Events
      27
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      182
      num Events
      68
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      177
      num Events
      18
    term
    Asthenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      187
      num Events
      20
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      182
      num Events
      15
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
      num Events
      3
    term
    Chills
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      187
      num Events
      88
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      182
      num Events
      147
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      177
      num Events
      78
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      187
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      182
      num Events
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Influenza like illness
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      187
      num Events
      5
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      182
      num Events
      14
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      177
      num Events
      6
    term
    Malaise
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      187
      num Events
      7
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      182
      num Events
      45
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      177
      num Events
      29
    term
    Mucosal inflammation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      187
      num Events
      16
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      182
      num Events
      32
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      177
      num Events
      16
    term
    Oedema peripheral
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      187
      num Events
      32
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      182
      num Events
      61
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      177
      num Events
      20
    term
    Pyrexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      187
      num Events
      19
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      182
      num Events
      21
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      177
      num Events
      20
    term
    Abdominal distension
Complete source fields
description
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. The mortality analysis set included all randomized participants. The AE and SAE analysis set included participants who received at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    122
    deaths Num At Risk
    187
    description
    Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
    id
    EG000
    other Num Affected
    173
    other Num At Risk
    187
    serious Num Affected
    72
    serious Num At Risk
    187
    title
    Avelumab
  2. deaths Num Affected
    107
    deaths Num At Risk
    182
    description
    Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
    id
    EG001
    other Num Affected
    176
    other Num At Risk
    182
    serious Num Affected
    74
    serious Num At Risk
    182
    title
    Avelumab + PLD
  3. deaths Num Affected
    116
    deaths Num At Risk
    177
    description
    PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
    id
    EG002
    other Num Affected
    167
    other Num At Risk
    177
    serious Num Affected
    51
    serious Num At Risk
    177
    title
    Pegylated Liposomal Doxorubicin (PLD)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      187
      num Events
      68
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      182
      num Events
      131
    3. group Id
      EG002
      num Affected
      42
      num At Risk
      177
      num Events
      77
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      187
      num Events
      2
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      182
      num Events
      58
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      177
      num Events
      52
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      187
      num Events
      11
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      182
      num Events
      22
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      177
      num Events
      2
    term
    Hypothyroidism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      187
      num Events
      27
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      182
      num Events
      68
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      177
      num Events
      18
    term
    Asthenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      187
      num Events
      20
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      182
      num Events
      15
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
      num Events
      3
    term
    Chills
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      187
      num Events
      88
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      182
      num Events
      147
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      177
      num Events
      78
    term
    Fatigue
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      187
      num Events
      7
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      182
      num Events
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Influenza like illness
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      187
      num Events
      5
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      182
      num Events
      14
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      177
      num Events
      6
    term
    Malaise
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      187
      num Events
      7
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      182
      num Events
      45
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      177
      num Events
      29
    term
    Mucosal inflammation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      187
      num Events
      16
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      182
      num Events
      32
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      177
      num Events
      16
    term
    Oedema peripheral
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      187
      num Events
      32
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      182
      num Events
      61
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      177
      num Events
      20
    term
    Pyrexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      187
      num Events
      19
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      182
      num Events
      21
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      177
      num Events
      20
    term
    Abdominal distension
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      182
      num Events
      1
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      177
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      182
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      187
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Atrial fibrillation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      182
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Myocardial infarction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      182
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Basedow's disease
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      182
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Hypopituitarism
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      187
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Retinal detachment
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      177
      num Events
      1
    term
    Administration site extravasation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      187
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      182
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Asthenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      187
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      182
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      177
      num Events
      0
    term
    Chest discomfort
time Frame
AEs (serious and non-serious) should be reported from the time of the first dose of study treatment through a minimum of 30 days + last dose of study treatment, start day of new anti-cancer therapy -1 day (up to 70 months). Based on the cutoff: 13 July 2022.

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Preserved source evidence · Not medical advice