Trial Outcomes & Findings for A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer (NCT NCT01421472)

Last Updated: 2016-05-03

Results Overview

Pathologic Complete Response was defined as the absence of invasive cancer in the breast and lymph nodes following completion of neoadjuvant systemic therapy and reported according to the current AJCC staging system for neoadjuvant clinical studies. The endpoint was to determine the pathologic Complete Response (pCR) rates associated with weekly treatment of MM-121 plus paclitaxel followed by the combination treatment of doxorubicin plus cyclophosphamide compared with weekly paclitaxel alone followed by the combination treatment of doxorubicin plus cyclophosphamide in patients with human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

196 participants

Primary outcome timeframe

At time of surgery, an expected average of 24-26 weeks

Results posted on

2016-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	HR+: MM-121+ Paclitaxel Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	HR+: Paclitaxel Only Hormone-receptor positive (HR+) sub-group randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	TN: MM-121 + Paclitaxel Triple Negative (TN) patients randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	TN: Paclitaxel Triple negative (TN) patients randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Overall Study STARTED	67	33	64	32
Overall Study COMPLETED	67	33	64	32
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HR+: MM-121+ Paclitaxel n=67 Participants Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	HR+: Paclitaxel Only n=33 Participants Hormone-receptor positive (HR+) sub-group randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	TN: MM-121 + Paclitaxel n=64 Participants Triple Negative (TN) patients randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	TN: Paclitaxel n=32 Participants Triple negative (TN) patients randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	Total n=196 Participants Total of all reporting groups
Age, Continuous	50.7 years STANDARD_DEVIATION 10.35 • n=5 Participants	48.9 years STANDARD_DEVIATION 10.53 • n=7 Participants	49.3 years STANDARD_DEVIATION 10.89 • n=5 Participants	52.5 years STANDARD_DEVIATION 13.45 • n=4 Participants	50.25 years STANDARD_DEVIATION 11.12 • n=21 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants	32 Participants n=4 Participants	196 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	3 Participants n=4 Participants	36 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	22 Participants n=7 Participants	51 Participants n=5 Participants	29 Participants n=4 Participants	159 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants	5 Participants n=4 Participants	27 Participants n=21 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants	26 Participants n=4 Participants	157 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment United States	67 participants n=5 Participants	33 participants n=7 Participants	64 participants n=5 Participants	32 participants n=4 Participants	196 participants n=21 Participants
Subject of Child-Bearing Potential (Y/N) Yes	32 participants n=5 Participants	19 participants n=7 Participants	27 participants n=5 Participants	12 participants n=4 Participants	90 participants n=21 Participants
Subject of Child-Bearing Potential (Y/N) No	35 participants n=5 Participants	14 participants n=7 Participants	37 participants n=5 Participants	20 participants n=4 Participants	106 participants n=21 Participants

PRIMARY outcome

Timeframe: At time of surgery, an expected average of 24-26 weeks

Population: Subjects with evaluable resection.

Outcome measures

Outcome measures
Measure	HR+: MM-121+ Paclitaxel n=66 Participants Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	HR+: Paclitaxel Only n=30 Participants Hormone-receptor positive (HR+) sub-group randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	TN: MM-121 + Paclitaxel n=56 Participants Triple Negative (TN) patients randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	TN: Paclitaxel n=29 Participants Triple negative (TN) patients randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR) Subjects with no pCR	59 participants	29 participants	32 participants	14 participants
Number of Participants With Pathologic Complete Response (pCR) (Rate of pCR) Subjects with pCR	7 participants	1 participants	24 participants	15 participants

Adverse Events

HR+: MM-121+ Paclitaxel

Serious events: 14 serious events

Other events: 67 other events

Deaths: 0 deaths

HR+: Paclitaxel Only

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

TN: MM-121 + Paclitaxel

Serious events: 18 serious events

Other events: 64 other events

Deaths: 0 deaths

TN: Paclitaxel

Serious events: 5 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trial Manager

Merrimack Pharmaceuticals

Phone: 617-441-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	HR+: MM-121+ Paclitaxel n=67 participants at risk Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	HR+: Paclitaxel Only n=33 participants at risk Hormone-receptor positive (HR+) sub-group randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	TN: MM-121 + Paclitaxel n=64 participants at risk Triple Negative (TN) patients randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	TN: Paclitaxel n=32 participants at risk Triple negative (TN) patients randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Blood and lymphatic system disorders Febrile Neutropenia	7.5% 5/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.4% 6/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Blood and lymphatic system disorders Anemia	4.5% 3/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 4/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Blood and lymphatic system disorders Neutropenia	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	4.7% 3/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Blood and lymphatic system disorders Leukopenia	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Bacteremia	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Breast Cellulutis	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Cellulitis	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Clostridial Infection	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Gastroenteritis	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Infected Cyst	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Infective Thrombosis	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Influenza	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Lung Infection	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Pneumonia	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Sepsis	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Staphylococcal Infection	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Infections and infestations Urinary Tract Infection	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Metabolism and nutrition disorders Dehydration	3.0% 2/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Metabolism and nutrition disorders Hyperkalemia	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Metabolism and nutrition disorders Hypovolemia	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	4.7% 3/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Diarrhea	3.0% 2/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Nausea	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Vomiting	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Pancreatitis	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Vascular disorders Hypertension	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Vascular disorders Hypotension	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Vascular disorders Jugular Vein Thrombosis	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Vascular disorders Thrombophlebitis	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
General disorders Pyrexia	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Injury, poisoning and procedural complications Infusion Related Reaction	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Injury, poisoning and procedural complications Seroma	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Nervous system disorders Presyncope	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Nervous system disorders Syncope	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Cardiac disorders Sinus Tachycardia	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Investigations Electrocardiogram QT Prolonged	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.

Other adverse events
Measure	HR+: MM-121+ Paclitaxel n=67 participants at risk Hormone-receptor positive (HR+) sub-group randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	HR+: Paclitaxel Only n=33 participants at risk Hormone-receptor positive (HR+) sub-group randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.	TN: MM-121 + Paclitaxel n=64 participants at risk Triple Negative (TN) patients randomized to receive: 2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)	TN: Paclitaxel n=32 participants at risk Triple negative (TN) patients randomized to receive: Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Gastrointestinal disorders Nausea	77.6% 52/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	72.7% 24/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	75.0% 48/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	75.0% 24/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Diarrhea	82.1% 55/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	36.4% 12/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	87.5% 56/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	46.9% 15/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Constipation	17.9% 12/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	39.4% 13/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	42.2% 27/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	46.9% 15/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Vomiting	23.9% 16/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	30.3% 10/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	26.6% 17/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	21.9% 7/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Dyspepsia	19.4% 13/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	24.2% 8/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	28.1% 18/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	25.0% 8/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Stomatitis	23.9% 16/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.1% 2/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	31.2% 20/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	21.9% 7/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Gastroesophageal Reflux Disease	19.4% 13/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	12.1% 4/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	17.2% 11/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.4% 3/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Abdominal Pain	10.4% 7/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	12.1% 4/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	15.6% 10/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Oral Pain	14.9% 10/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.1% 2/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	12.5% 8/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Hemorrhoids	9.0% 6/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	14.1% 9/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Dry Mouth	7.5% 5/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.1% 3/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Proctalgia	7.5% 5/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Toothache	0.00% 0/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	7.8% 5/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Dysphagia	3.0% 2/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.1% 2/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Abdominal Distension	4.5% 3/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Abdominal Pain Upper	3.0% 2/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.1% 2/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Gastrointestinal disorders Mouth Ulceration	3.0% 2/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Alopecia	62.7% 42/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	66.7% 22/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	65.6% 42/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	65.6% 21/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Rash	41.8% 28/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	15.2% 5/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	42.2% 27/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	25.0% 8/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Nail Disorder	13.4% 9/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.1% 3/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	25.0% 16/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.4% 3/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Pruritis	10.4% 7/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	15.2% 5/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	14.1% 9/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	12.5% 4/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Dry Skin	13.4% 9/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	15.6% 10/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.4% 3/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Nail Discoloration	16.4% 11/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.1% 2/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.4% 6/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	12.5% 4/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	9.0% 6/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.1% 2/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.4% 6/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Rash Maculo-papular	9.0% 6/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 4/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Erythema	7.5% 5/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	4.7% 3/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Skin Discoloration	6.0% 4/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.1% 2/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysasthesia Syndrome	4.5% 3/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 4/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Rash Pruritic	7.5% 5/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	4.7% 3/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Onycholysis	6.0% 4/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Pain of Skin	7.5% 5/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 2/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Nail Bed Tenderness	6.0% 4/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.1% 1/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Night Sweats	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.1% 2/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	1.6% 1/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Rash Macular	1.5% 1/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	4.7% 3/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
Skin and subcutaneous tissue disorders Dermatitis Acneform	3.0% 2/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	3.0% 1/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	0.00% 0/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	6.2% 2/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
General disorders Fatigue	80.6% 54/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	63.6% 21/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	78.1% 50/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	87.5% 28/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
General disorders Mucosal Inflammation	25.4% 17/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	15.2% 5/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	17.2% 11/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	25.0% 8/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
General disorders Pyrexia	25.4% 17/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	24.2% 8/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	12.5% 8/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	18.8% 6/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
General disorders Peripheral edema	14.9% 10/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	27.3% 9/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	17.2% 11/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	18.8% 6/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.
General disorders Pain	3.0% 2/67 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.1% 3/33 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	12.5% 8/64 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.	9.4% 3/32 • Adverse events were collected from a patient's first dose until 30 days after treatment termination. Serious adverse events were collected from time of informed consent until 30 days after treatment termination, or any time when assumed to be related All related AEs ongoing at the time of treatment discontinuation were followed until resolution. Investigators were to report any AEs/SAEs assumed to be related any time, even if occurring more than 30 days after last dose. Though different for each patient, on average, patients could be followed for related AEs/SAEs for \~1 year after termination.