......................................................... 32 7.1.2 Suspected Adverse Reaction..................................... ................................................ 32 7.1.3 Unexpected Adverse Reaction.................................... .............................................. 32 7.1.4 Serious....................................................................................................................... 32 7.1.5 Serious Adverse Event.......................................... .................................................... 32 7.1.6 Disability..................................................... .............................................................. 33 7.1.7 Life-Threatening Adverse Drug Experience....................... ...................................... 33 7.1.8 Protocol Deviation (NIH Definition)............................ ............................................ 33 7.1.9 Non-Compliance (NIH Definition)........................... ................................................