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NCT03674112 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-01-02

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 and deaths reporting timeframes during study treatment: Cross-Over Period: 3 cycles (cyc) of P+H IV & 3 cyc of PH FDC SC; Continuation Period: from Cyc 7 to 18 total cyc of P+H IV or PH FDC SC (1 cyc = 21 days); All Participants: from first dose through 28 days after last dose of study treatment (up to 1 year). Follow-up period: AEs reported from 29 days up to 7 months after the last dose of study treatment; deaths reported from 29 days after last dose until the end of follow-up (≥3 years).
Other-event reporting threshold
5%

After initiation of study treatment, all adverse events (AEs) regardless of relationship to study drug were to be reported until 28 days after the last dose of study drug. In the Follow-Up Period, the following AEs were to be reported: study drug-related serious AEs; AEs of special interest, heart failure, pregnancies, non-breast-related second primary malignancies and deaths, irrespective of causal relationship.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
P+H IV: Treatment Cross-Over Period

This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Cross-Over Period of the study.

6 / 16062 / 1600 / 160
PH FDC SC: Treatment Cross-Over Period

This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) during the Treatment Cross-Over Period of the study.

2 / 16084 / 1600 / 160
P+H IV: Treatment Continuation Period

This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).

0 / 2110 / 210 / 21
PH FDC SC: Treatment Continuation Period

This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).

4 / 13847 / 1380 / 138
All Participants: All Study Treatment Periods

This safety analysis population includes all participants from Arms A and B who received at least one dose of treatment with pertuzumab IV and trastuzumab IV (P+H IV) and/or the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) across any of the treatment periods during the study from first dose through 28 days after the last dose of study treatment.

11 / 160125 / 1600 / 160
Follow-Up Period

This safety analysis population includes all participants from Arms A and B who had received at least one dose of any study treatment and had not discontinued from the study prior to entering the follow-up period. The timeframe of the follow-up period started at 29 days after the last dose of study treatment until the end of follow-up (≥3 years after randomization of the last participant).

1 / 1592 / 1592 / 159

Group identifiers: EG000: P+H IV: Treatment Cross-Over Period · EG001: PH FDC SC: Treatment Cross-Over Period · EG002: P+H IV: Treatment Continuation Period · EG003: PH FDC SC: Treatment Continuation Period · EG004: All Participants: All Study Treatment Periods · EG005: Follow-Up Period

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
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      160
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Device related infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      138
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      160
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Erysipelas
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Breast cellulitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Bronchopulmonary aspergillosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Upper respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      160
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      160
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Ejection fraction decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      160
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Asthma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    COVID-19
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      160
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      159
      num Events
      1
    term
    Cardiac failure

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      160
      num Events
      20
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      160
      num Events
      19
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
      num Events
      4
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      138
      num Events
      23
    5. group Id
      EG004
      num Affected
      37
      num At Risk
      160
      num Events
      66
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      160
      num Events
      8
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      160
      num Events
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      138
      num Events
      8
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      160
      num Events
      29
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      160
      num Events
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      138
      num Events
      28
    5. group Id
      EG004
      num Affected
      44
      num At Risk
      160
      num Events
      78
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Injection site reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      160
      num Events
      29
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      160
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      44
      num At Risk
      160
      num Events
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Radiation skin injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      160
      num Events
      9
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      138
      num Events
      6
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      160
      num Events
      26
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      159
      num Events
      1
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      160
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Bone pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      160
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      160
      num Events
      12
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      159
      num Events
      1
    term
    Myalgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      160
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      160
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      160
      num Events
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      160
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      160
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      138
      num Events
      3
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      160
      num Events
      12
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Rash
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      160
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      138
      num Events
      3
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      160
      num Events
      19
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Hot flush
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      160
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      138
      num Events
      5
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      160
      num Events
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      159
      num Events
      1
    term
    Pain in extremity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      160
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      160
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      138
      num Events
      7
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      160
      num Events
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Pruritus
Complete source fields
description
After initiation of study treatment, all adverse events (AEs) regardless of relationship to study drug were to be reported until 28 days after the last dose of study drug. In the Follow-Up Period, the following AEs were to be reported: study drug-related serious AEs; AEs of special interest, heart failure, pregnancies, non-breast-related second primary malignancies and deaths, irrespective of causal relationship.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    160
    description
    This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Cross-Over Period of the study.
    id
    EG000
    other Num Affected
    62
    other Num At Risk
    160
    serious Num Affected
    6
    serious Num At Risk
    160
    title
    P+H IV: Treatment Cross-Over Period
  2. deaths Num Affected
    0
    deaths Num At Risk
    160
    description
    This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) during the Treatment Cross-Over Period of the study.
    id
    EG001
    other Num Affected
    84
    other Num At Risk
    160
    serious Num Affected
    2
    serious Num At Risk
    160
    title
    PH FDC SC: Treatment Cross-Over Period
  3. deaths Num Affected
    0
    deaths Num At Risk
    21
    description
    This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    21
    serious Num Affected
    0
    serious Num At Risk
    21
    title
    P+H IV: Treatment Continuation Period
  4. deaths Num Affected
    0
    deaths Num At Risk
    138
    description
    This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).
    id
    EG003
    other Num Affected
    47
    other Num At Risk
    138
    serious Num Affected
    4
    serious Num At Risk
    138
    title
    PH FDC SC: Treatment Continuation Period
  5. deaths Num Affected
    0
    deaths Num At Risk
    160
    description
    This safety analysis population includes all participants from Arms A and B who received at least one dose of treatment with pertuzumab IV and trastuzumab IV (P+H IV) and/or the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) across any of the treatment periods during the study from first dose through 28 days after the last dose of study treatment.
    id
    EG004
    other Num Affected
    125
    other Num At Risk
    160
    serious Num Affected
    11
    serious Num At Risk
    160
    title
    All Participants: All Study Treatment Periods
  6. deaths Num Affected
    2
    deaths Num At Risk
    159
    description
    This safety analysis population includes all participants from Arms A and B who had received at least one dose of any study treatment and had not discontinued from the study prior to entering the follow-up period. The timeframe of the follow-up period started at 29 days after the last dose of study treatment until the end of follow-up (≥3 years after randomization of the last participant).
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    159
    serious Num Affected
    1
    serious Num At Risk
    159
    title
    Follow-Up Period
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      160
      num Events
      20
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      160
      num Events
      19
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
      num Events
      4
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      138
      num Events
      23
    5. group Id
      EG004
      num Affected
      37
      num At Risk
      160
      num Events
      66
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      160
      num Events
      8
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      160
      num Events
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      138
      num Events
      8
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      160
      num Events
      29
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      160
      num Events
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      138
      num Events
      28
    5. group Id
      EG004
      num Affected
      44
      num At Risk
      160
      num Events
      78
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Injection site reaction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      160
      num Events
      29
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      160
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      44
      num At Risk
      160
      num Events
      47
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Radiation skin injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      160
      num Events
      9
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      138
      num Events
      6
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      160
      num Events
      26
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      159
      num Events
      1
    term
    Arthralgia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      160
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Bone pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      160
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      160
      num Events
      12
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      159
      num Events
      1
    term
    Myalgia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      160
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      160
      num Events
      6
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      160
      num Events
      13
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Headache
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      160
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      160
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      138
      num Events
      3
    5. group Id
      EG004
      num Affected
      10
      num At Risk
      160
      num Events
      12
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Rash
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      160
      num Events
      6
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      160
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      138
      num Events
      3
    5. group Id
      EG004
      num Affected
      16
      num At Risk
      160
      num Events
      19
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Hot flush
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      160
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      2
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      138
      num Events
      5
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      160
      num Events
      13
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      159
      num Events
      1
    term
    Pain in extremity
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      160
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      160
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      138
      num Events
      7
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      160
      num Events
      18
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Pruritus
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      160
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Device related infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      138
      num Events
      2
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      160
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Erysipelas
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Breast cellulitis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Bronchopulmonary aspergillosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Upper respiratory tract infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      160
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      160
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      160
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Ejection fraction decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      160
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    Asthma
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      138
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      160
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      159
      num Events
      0
    term
    COVID-19
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      160
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      160
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      138
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      160
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      159
      num Events
      1
    term
    Cardiac failure
time Frame
AEs and deaths reporting timeframes during study treatment: Cross-Over Period: 3 cycles (cyc) of P+H IV & 3 cyc of PH FDC SC; Continuation Period: from Cyc 7 to 18 total cyc of P+H IV or PH FDC SC (1 cyc = 21 days); All Participants: from first dose through 28 days after last dose of study treatment (up to 1 year). Follow-up period: AEs reported from 29 days up to 7 months after the last dose of study treatment; deaths reported from 29 days after last dose until the end of follow-up (≥3 years).

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