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NCT03107988 · ADVERSE EVENTS

Adverse events

NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) · Source last updated 2025-09-15

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
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A1 DL1

Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

1 / 33 / 32 / 3
Cohort A1 DL2

Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

1 / 33 / 33 / 3
Cohort A1 DL3

Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

0 / 33 / 32 / 3
Cohort A1 DL4

Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

3 / 109 / 109 / 10
Cohort A1 DL5

Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

2 / 66 / 63 / 6
Cohort A2 DL 3A

Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

4 / 66 / 64 / 6
Cohort A2 DL4A

Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

3 / 66 / 62 / 6
Cohort A2 DL4A Expansion

Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

1 / 44 / 40 / 4
Cohort B1 DL5

Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.

3 / 55 / 53 / 5
Cohort B2 DL4B

Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.

3 / 33 / 32 / 3
Cohort B2 DL5B

Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.

10 / 1312 / 137 / 13
Cohort B2 DL3A

Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.

1 / 11 / 10 / 1
Cohort B2 DL4A

Lorlatinib will be given orally once daily continuously for 28 days at 150mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.

1 / 11 / 10 / 1

Group identifiers: EG000: Cohort A1 DL1 · EG001: Cohort A1 DL2 · EG002: Cohort A1 DL3 · EG003: Cohort A1 DL4 · EG004: Cohort A1 DL5 · EG005: Cohort A2 DL 3A · EG006: Cohort A2 DL4A · EG007: Cohort A2 DL4A Expansion · EG008: Cohort B1 DL5 · EG009: Cohort B2 DL4B · EG010: Cohort B2 DL5B · EG011: Cohort B2 DL3A · EG012: Cohort B2 DL4A

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      6
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Duodenal obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Flu like symptoms
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Multi-organ failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    TRANSFUSION-ASSOCIATED CIRCULATORY OVERLOAD
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    BILIARY OBSTRUCTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    COVID 19
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Catheter related infection

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      12
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Atrioventricular block first degree
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Sinus bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      5
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Hearing impaired
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Hypothyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    ABNORMAL EYE MOVEMENTS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Blurred vision
Complete source fields
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 45 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Cohort A1 DL1
  2. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 60 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Cohort A1 DL2
  3. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 75 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Cohort A1 DL3
  4. deaths Num Affected
    9
    deaths Num At Risk
    10
    description
    Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 95 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    3
    serious Num At Risk
    10
    title
    Cohort A1 DL4
  5. deaths Num Affected
    3
    deaths Num At Risk
    6
    description
    Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG004
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    Cohort A1 DL5
  6. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Lorlatinib will be given at 100 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG005
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    4
    serious Num At Risk
    6
    title
    Cohort A2 DL 3A
  7. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG006
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Cohort A2 DL4A
  8. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Lorlatinib will be given at 150 mg orally once daily continuously for 28 days. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG007
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Cohort A2 DL4A Expansion
  9. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    Lorlatinib will be given orally once daily continuously for 28 days. The dose level of lorlatinib will be 115 mg/m2/dose. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
    id
    EG008
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Cohort B1 DL5
  10. deaths Num Affected
    2
    deaths Num At Risk
    3
    description
    Lorlatinib will be given orally once daily continuously for 28 days at 95mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
    id
    EG009
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Cohort B2 DL4B
  11. deaths Num Affected
    7
    deaths Num At Risk
    13
    description
    Lorlatinib will be given orally once daily continuously for 28 days at 115mg/m2/dose. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be under 18 years of age at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
    id
    EG010
    other Num Affected
    12
    other Num At Risk
    13
    serious Num Affected
    10
    serious Num At Risk
    13
    title
    Cohort B2 DL5B
  12. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Lorlatinib will be given orally once daily continuously for 28 days at 100mg/day. Lorlatinib should be administered at least one hour prior to conventional chemotherapy (Cyclophosphamide and Topotecan) on days 1-5 of each cycle. Patients must be 18 years of age or older at time of enrollment. Lorlatinib: Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets. Cyclophosphamide: Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle Topotecan: Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle Filgrastim/pegfilgrastim: Filgrastim is to be given with each course beginning 24-48 hours following completion of cyclophosphamide and topotecan and continued through post-nadir count recovery with an ANC \> 2000/mm\^3 at 5mcg/kg/day. Filgrastim must be discontinued at least 24 hours prior to the start of the next course of therapy. Pegfilgrastim (100mcg/kg; 6mg maximum dose) may be substituted and is given one time at 24-48 hours from completion of cyclophosphamide and topotecan.
    id
    EG011
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Cohort B2 DL3A
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      12
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Atrioventricular block first degree
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Sinus bradycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      5
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Hearing impaired
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Tinnitus
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Hypothyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    ABNORMAL EYE MOVEMENTS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Blurred vision
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      6
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Blurred vision
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Duodenal obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      1
    term
    Flu like symptoms
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Multi-organ failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    TRANSFUSION-ASSOCIATED CIRCULATORY OVERLOAD
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    BILIARY OBSTRUCTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    COVID 19
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      6
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      6
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      6
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      4
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      5
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      3
    11. group Id
      EG010
      num Affected
      3
      num At Risk
      13
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      1
    term
    Catheter related infection
time Frame
Timeframe from enrollment through 30 days following end of protocol therapy, an average of 10 months

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

Preserved source evidence · Independent clinical review pending · Not medical advice